Beijing Dingcheng Peptide Source Biotech Co., Ltd.

This study is an open-label, single-arm, multicenter Phase I clinical trial consisting of a dose-escalation phase (Phase Ia) and a cohort-expansion phase (Phase Ib).
Phase Ia (Dose Escalation) aims to evaluate the safety and tolerability of DCTY1102 Injection in patients with advanced solid tumors positive for KRAS G12D mutation and HLA-A*11:01 genotype, observe potential dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), characterize the pharmacokinetic (PK) profile of DCTY1102 following infusion, assess its in vivo proliferation and persistence, preliminarily evaluate therapeutic efficacy, and investigate immunogenicity.
Phase Ib (Cohort Expansion) will be conducted after establishing MTD and/or RP2D in Phase Ia. This phase further evaluates the preliminary efficacy, safety, PK profile, and immunogenicity of DCTY1102 Injection in patients with KRAS G12D mutation-positive, HLA-A*11:01 genotype tumors, including colorectal cancer, pancreatic cancer, or other malignancies. The study plans to establish 2-3 cohorts:
Cohort 1: Colorectal cancer
Cohort 2: Pancreatic cancer
Cohort 3: Other tumor types
Each cohort will enroll approximately 15-31 patients who will receive DCTY1102 infusion at the MTD and/or RP2D dose levels identified in Phase Ia.

评估DCTY1102注射液治疗KRASG12D突变阳性、基因型为 HLA-A 11:01的晚期实体瘤患者的安全性和耐受性，确定最大耐受剂量(MTD)(如有)和推荐2期剂量(RP2D)。